Yasmin - The Suits Keep Coming
During the same week that a generic formulation of the oral contraceptive Yasmin was approved, several new lawsuits were filed against Bayer, the original producers of the drug. Once again, the suits focus on the lack of information and the general disinformation provided by Bayer to patients concerning the risks and truths about this contraceptive, which is alleged to cause thickened blood, blood clots and ischemic stroke.
The first suit was filed in Cincinnati, Ohio. The plaintiff in this case has alleged that the documentation provided for Yasmin's sister drug, Yaz, was inconsistent and scattered. Warnings would be buried deep inside the paperwork while other facts were repeated pointlessly in numerous places. A second lawsuit that was filed in Canada alleged much the same thing. Both also are asserting that the documents did too little to explain the risk of potential blood clots and damages that could be caused by taking these oral contraceptives for too long. Furthermore, the Canadian plaintiff is suing for actual damages relating to a stroke she suffered — a stroke she claims was caused by taking Yasmin. In addition, she suffered gallstones during the treatment cycle, requiring her gallbladder to be removed.
More than 2,000 lawsuits have been filed against Bayer and its distributors to date for just the above reasons.
And yet despite the continuing rate of lawsuits being filed, the FDA has elected to approve a generic formulation of Yasmin, to be produced under the name Zarah. The Abbreviated Drug Application was approved earlier last week, allowing Watson Laboratories to go forward with the manufacture and eventual sale of the generic drug, which is fundamentally identical to Bayer's contraceptive, carrying the same risks and side effects that its parent drug has.
There is no way to phrase this without wondering exactly what the FDA is thinking: Why go forward and approve a generic form of Yasmin at a time when the very safety of the drug is still being called into question?
